Forma Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating FT-7051 for the Treatment of Metastatic...
20 January 2021 - 11:05PM
Business Wire
Phase 1 study includes late-line patients and
patients with AR-v7 splice variants for whom there are no approved
therapies
FT-7051 is a selective inhibitor of
CREB-binding protein/E1A binding protein p300 (CBP/p300) and a
co-activator of androgen receptor
In prostate cancer cell lines in vitro, FT-7051
demonstrated inhibition of AR-dependent gene expression and a
reduction in androgen receptor expression; also demonstrated
antiproliferative activity in AR-positive prostate cancer cell
lines, including resistance variant AR-v7 positive models
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on rare
hematologic diseases and cancers, today announced that the first
patient has been dosed in a Phase 1 clinical trial evaluating
FT-7051, a selective inhibitor of CBP/p300, a known co-activator of
the androgen receptor (AR) in men with metastatic
castration-resistant prostate cancer (mCRPC).
“While a patient with mCRPC may initially respond to standard
anti-androgen therapies, a significant unmet need persists since
nearly all patients ultimately become resistant to these
treatments,” said David N. Cook, Ph.D., chief scientific officer of
Forma Therapeutics. “Initiating enrollment in this Phase 1 trial is
an important step toward our goal of providing mCRPC patients with
an additional therapeutic option to treat this severe illness.”
Study Design
The Phase 1 trial is a multicenter, open-label evaluation of the
safety and tolerability, preliminary anti-tumor activity (PSA and
radiographic responses), and pharmacokinetics/pharmacodynamics
(PK/PD) of FT-7051 in men with mCRPC who have progressed despite
prior therapy and have been treated with at least one potent
anti-androgen therapy. This is an adaptive trial design, intended
to accelerate the escalation to potentially therapeutic doses and
yield important safety information. More information about this
trial may be accessed at Clinicaltrials.gov (identifier:
NCT04575766).
About FT-7051
FT-7051 is a selective inhibitor of CREB-binding protein/E1A
binding protein p300 (CBP/p300) and a co-activator of androgen
receptor (AR). In prostate cancer cell lines in vitro, FT-7051
demonstrated inhibition of AR-dependent gene expression and
reductions in androgen receptor expression. FT-7051 also
demonstrated antiproliferative activity in AR-positive prostate
cancer cell lines, including resistance variant AR-v7 positive
models.
About Metastatic Castration-resistant Prostate Cancer
Prostate cancer is the second leading cause of cancer death for
men in the U.S., and mCRPC is the most advanced form of this
disease. Prostate cancer cell growth is driven by activity of the
androgen receptor (AR). Primary treatments of mCRPC include
therapies that reduce androgen synthesis or inhibit androgen
binding and activation of the AR. Studies have shown that
approximately 20% to 40% of mCRPC patients demonstrate primary
resistance to enzalutamide and abiraterone acetate, two commonly
used therapies, and virtually all patients who demonstrate initial
clinical responses eventually acquire resistance. There are
currently no approved therapies specifically aimed at mCRPC
over-expressing AR variants, including AR-v7; therefore, a novel
inhibitor of AR co-activator CBP/p300 may play a role in the
suppression of mCRPC driven by AR aberrations.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company
focused on the research, development and commercialization of novel
therapeutics to transform the lives of patients with rare
hematologic diseases and cancers. Our R&D engine combines deep
biology insight, chemistry expertise and clinical development
capabilities to create drug candidates with differentiated
mechanisms of action focused on indications with high unmet need.
Our work has generated a broad proprietary portfolio of programs
with the potential to provide profound patient benefit. For more
information, please visit www.FormaTherapeutics.com or follow us on
Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, express or implied
statements regarding: our guidance regarding our business plans and
objectives for FT-7051, including the therapeutic potential and
clinical benefits thereof as well as the planned study design, the
timing and success of ongoing clinical trials, our growth as a
company, and the potential impact of COVID-19 on patient retention,
strategy, future operations and clinical trials. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, those risks and
uncertainties related to the advancement of our clinical programs,
our ability to execute on our strategy, that positive interim
results from a clinical study may not be necessarily predictive of
the results of future or ongoing clinical studies, the regulatory
developments in the United States, the risks related to the
competitive landscape, and other risks identified in our SEC
filings, including those risks discussed under the heading “Risk
Factors” in our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2020, as well as other risks detailed in our
subsequent filings with the SEC. We caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. We disclaim any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20210120005136/en/
Media Contact: Megan McGrath, +1 781-591-3488 MacDougall
mmcgrath@macbiocom.com
Investor Contact: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
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